Confluence and Jira in Quality Management System
The QMS Built on Tools Your Teams Already Use
Confluence and Jira don’t have to be just your collaboration tools — they can become your compliant electronic QMS.
Atlassian tools like Confluence and Jira are widely adopted across industries. These tools gained their popularity for their:
- intuitive and user-friendly interface
- fast and straightforward implementation
- scalability and flexibility across teams
- strength in collaboration
But when it comes to quality management systems (QMS) in medical devices, doubts might arise:
“Can a QMS based on Confluence and Jira be compliant with ISO 13485, IEC 62304, or FDA 21 CFR 820?”
“Are electronic records and signatures in Confluence accepted by auditors?”
The short answer: Yes!
Confluence and Jira as Your eQMS Compliant Tools
With the right strategy and setup, Confluence and Jira can fully support:
- QMS and Quality System Regulation based on ISO 13485 or FDA 21 CFR 820
- IEC 62304 design controls for medical device software
- 21 CFR Part 11 requirements on electronic records and signatures
- Good Documentation Practice (GxP)
Our Expertise Proven in Audits
We have guided numerous medical device companies through ISO 13485 certification audits, FDA inspections under 21 CFR 820, and notified body EU MDR audits.
By preparing their Confluence- and Jira-based eQMS with the right configurations, documentation structure, and regulatory anchoring, these companies were able to demonstrate their full compliance with applicable standards and regulations.
Our consulting approach ensures that:
- audit readiness is built into your daily QMS operations
- Atlassian tools are tailored to meet ISO, IEC, and FDA requirements
- your teams can work confidently in tools they already know and love
“Choose the right partner with both regulatory and technical expertise — and ensure your eQMS compliance.”
Confluence as a Document Management System
Confluence can be more than a collaboration hub — it can become your compliant, structured, and audit-ready document management system.
Teams love Confluence for its simplicity, collaboration features, and intuitive content management. Information flows fast, knowledge is easily shared, and adoption comes naturally.
But when it comes to a quality management system (QMS), good operations require more than just content sharing. Documents shall be organized and controlled as defined in the ISO 13485 standard or the FDA 21 CFR 820 regulation.
Turning Confluence into a Driver of Operational Excellence
As organizations grow, content in Confluence often expands organically. Without structure, it can become challenging to:
- Ensure information is always up-to-date
- Apply a reliable access control process to sensitive information
- Ensure standardized authoring, reviewing, and approving procedures
- Distribute documents effectively to the right audiences
That’s why ISO 13485 QMS and Good Documentation Practices (GxP) demand clear rules:
- Controlled versioning (which version was effective, when, and for whom)
- Archiving procedures for historical documents
- Audit trail and logs for regulatory inspections
- Review and approval workflows that ensure accountability
“With QML Logic at your side, Confluence goes beyond compliance to deliver the structure every growing organization needs.”
How We Support You Make Confluence QMS-Ready
We help organizations design a compliant documentation architecture in Confluence with:
- Structured naming convention and versioning system
- Defined archiving process aligned with applicable norms and regulations
- Integration of proven third-party modules for access control, approvals, and audit trails
- Aligned workflows for document reviews, approval, and distribution
Going Beyond Standard Setup
Where standard Confluence features or add-ons are not enough, we build customized solutions tailored to our clients’ needs.
You can rely on us when it comes to:
- Dashboards for document monitoring and KPIs
- Automation scripts for repetitive or bulk operations
- API integrations for advanced workflows and system interoperability
“With the right design, Confluence becomes more than compliant — it becomes fast, convenient, and empowering for your teams.”
Jira Across Development, Operations, and Compliance
Jira is widely used both in product development, from requirements engineering, agile workflows, testing, and design reviews, and in operational processes such as complaint handling, incident reporting, and problem resolution. Its flexibility makes it a backbone for engineering teams and support functions alike.
From Everyday Use to Regulatory Compliance
What makes this relevant for medical device companies is that these same activities, requirements engineering, verification, complaint handling, and change management, are also core elements of ISO 13485, IEC 62304, MDR, and FDA QSR.
At QMLogic, we bring these worlds together:
- Configuring Jira for end-to-end traceability from requirements to verification
- Embedding audit trails and controlled electronic records
- Supporting automated generation of technical documentation for regulators
- Closing gaps so that your existing Jira workflows meet regulatory expectations
“With QMLogic, Jira evolves from an everyday project tool into a compliant, audit-ready QMS platform.”
Beyond Core Jira: Tailored Solutions for QMS
Setting up Jira’s core functionalities is just the first, yet important step. At QMLogic, we help companies go further by integrating third-party modules that extend Jira’s capabilities for:
- Requirements engineering and traceability
- Verification and testing activities
- Risk management aligned with ISO 14971
Every organization is different, and standard tools or add-ons cannot always reflect unique processes and regulatory needs. That’s why we design custom workflows and automations that go far beyond Jira’s core.
With our expertise, we:
- Build workflow automations using tools such as ScriptRunner or utilising Atlassian’s REST API
- Connect Jira with AI agents and large language models to support QA, consistency checks, and smart content generation
- Develop custom dashboards and review statistics that power KPI evaluation, trend analysis, and management review preparation
- Integrate Jira seamlessly with other systems in your organization, eliminating manual and repetitive work
Atlassian Tools Always Scalable, Always Compliant
With QMLogic, our clients can be certain that every Jira or Confluence setup, including integrated modules, custom workflows, and AI-powered solutions, is fully validated and compliant with the key standards for modern eQMS systems:
- ISO 80002-2 – validation of computerized systems
- ISO 42001 – lifecycle management of AI in quality systems
We ensure that your eQMS is not only configured to meet functional needs, but also audit-ready and validated according to these standards. This removes uncertainty and gives you confidence that your digital QMS infrastructure will stand up to regulatory scrutiny.
Questions and Answers
Q: Is Confluence QMS the right choice for my organization?
A: This depends largely on the size and complexity of your organization:
- For smaller organizations, setting up a QMS in Confluence is straightforward and can often be implemented within days or weeks. It offers an efficient, cost-effective solution for controlled document management.
- As organizations grow in size and complexity, additional requirements on document and record control may emerge. Many companies use Confluence successfully at first, but as their needs expand — e.g., managing contracts, invoices, HR records, and confidential information — Confluence may face limitations in access control, scalability, and information security.
From our experience:
- Up to ~50–60 people, Confluence as an eQMS is easy to set up, maintain, and operate.
- Beyond that scale, especially when hundreds of thousands of documents with different confidentiality levels are involved, maintaining compliance and security can become challenging.
In such cases, we help clients evaluate and transition to more robust solutions like SharePoint or enterprise-level IMS systems that better support large organizations while still ensuring compliance.
Q: Is Jira the right tool for medical device development?
A: The answer depends on what you use Jira for.
Jira works perfectly for managing sprints, user stories, epics, and agile artifacts, and it can be set up in full compliance with IEC 62304 and AAMI TIR45. We have implemented this approach multiple times, even with Jira as the only tool supporting the entire product lifecycle.
However, when Jira is used as a requirements or system engineering tool in larger and more complex projects, it was not originally designed for this purpose, and relying on it alone can become challenging.
Also, AAMI TIR45 distinguishes between formal design inputs/outputs and agile artifacts like needs, epics, or stories.
This doesn’t mean Jira cannot be used for design controls in medical device software development, but it requires proper configuration and linking of requirements, risks, and design outputs, supported by third-party tools or custom software add-ons, to ensure traceability and integrity of the technical file.
From our experience:
For smaller projects with dozens or up to a hundred requirements, Jira alone can be configured to fully support compliance.
For larger and more complex projects with multiple teams or system-of-systems approaches, we recommend separating the requirements engineering and design control process from the development process. In this setup, Jira remains the backbone for agile development, CI/CD, QA, and automated testing, while requirements and risks are managed in a dedicated system that integrates with Jira.
But using a requirements engineering tool should not prevent you from applying agile methods in Jira. While Jira has specific limitations in fulfilling certain regulations on its own, it excels as a collaboration tool, which is not a primary requirement for requirements engineering tools.